MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE RELINE SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	10001113
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cannula of a surgical instrument was blocked with cement and could not be used for a case.No case or patient impact was reported.Requests for information were made but no additional information was received.
Additional Manufacturer Narrative
No device was returned for evaluation and no photographs were provided for review; further, operative notes from the procedure were not provided for review of usage/technique.Based on the information obtained, the complaint could not be confirmed and a root cause of the reported event was unable to be determined conclusively, but may have been the result of user handling and technique.Labeling review: "pre-operative warnings the methods of use for the instruments are to be determined by the user¿s experience and training in surgical procedures.Do not use these instruments for any action for which it was not intended such as hammering, prying, or lifting.These instruments should be treated as any precision instrument and should be carefully placed on trays, cleaned after each use, and stored, according to generally accepted hospital methods and practices.The instruments should be carefully examined prior to use for functionality, excessive wear, or damage.A damaged instrument should not be used as this may increase the risk of malfunction and potential patient injury.The instruments should be inspected for damage prior to use.If they are bent or damaged in any way, they should not be used, regardless of navigated or manual procedures.In addition, periodically inspect the instruments for wear and tear, such as corrosion or discoloration.For instruments that are no longer functional, or exhibit excessive wear and tear, please return instruments to nuvasive.All sets should be carefully checked for completeness and all components should be carefully checked for signs of damage prior to use.Damaged packages or products should not be used and should be returned to nuvasive." "instruments should be protected during storage and from corrosive environments.All non-sterile parts should be cleaned and sterilized before use inspect all components for damage before use.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.Refer to cleaning and sterilization instructions below for all non-sterile parts.Do not use pedicle screws from fixation systems other than reline and vuepoint.The nuvasive navigation.S instruments should not be bent or altered in any way.If damage is observed, the instrument should not be used and returned to nuvasive." "cleaning and decontamination all non-sterile instruments must first be thoroughly cleaned using the validated methods prescribed in the nuvasive cleaning and sterilization instructions (doc #9400896) before sterilization and introduction into a sterile surgical field.Contaminated instruments should be wiped clean of visible soil at the point of use, prior to transfer to a central processing unit for cleaning and sterilization.The validated cleaning methods include both manual and automated cleaning.Visually inspect the instruments following performance of the cleaning instructions to ensure there is no visual contamination of the instruments prior to proceeding with sterilization.If possible, contamination is present at visual inspection, repeat the cleaning steps.Contaminated instruments should not be used, and should be returned to nuvasive.Contact your local representative or nuvasive directly for any additional information related to cleaning of nuvasive surgical instruments.".

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: patrick yrigoyen ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 19996264
• Report Number: 2031966-2024-00193
• Device Sequence Number: 12503667
• Product Code: LXH
• UDI-Device Identifier: 00887517948342
• UDI-Public: 887517948342
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10001113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown